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Table 7 Percentage of patients in integrated double-blind studies who experienced a hypersensitivity eventa,b

From: Correction to: Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies

  

Galcanezumab

Placebo

N = 1451

n (%)

120 mg

N = 705

n (%)

240 mg

N = 730

n (%)

Hypersensitivity SMQ

40 (2.8)

34 (4.8)c

32 (4.4)c

 Rash

15 (1.0)

5 (0.7)

7 (1.0)

 Injection site rash

2 (0.1)

6 (0.9)c

4 (0.6)

 Dermatitis contact

4 (0.3)

3 (0.4)

4 (0.6)

 Rhinitis allergic

3 (0.2)

3 (0.4)

4 (0.6)

 Hypersensitivity

0 (0.0)

3 (0.4)c

2 (0.3)c

 Injection site hypersensitivity

0 (0.0)

1 (0.1)

3 (0.4)c

 Dermatitis allergic

0 (0.0)

3 (0.4)c

0 (0.0)

 Eczema

3 (0.2)

1 (0.1)

2 (0.3)

 Rash pruritic

0 (0.0)

2 (0.3)c

1 (0.1)

 Urticaria

5 (0.3)

2 (0.3)

1 (0.1)

 Injection site urticaria

1 (0.1)

1 (0.1)

1 (0.1)

 Rash generalized

1 (0.1)

1 (0.1)

1 (0.1)

 Rash papulosquamous

0 (0.0)

1 (0.1)

1(0.1)

 Dermatitis atopic

1 (0.1)

0 (0.0)

1(0.1)

 Eye allergy

0 (0.0)

1 (0.1)

0 (0.0)

 Pruritus allergic

0 (0.0)

1 (0.1)

0 (0.0)

 Rash erythematous

1 (0.1)

0 (0.0)

1 (0.1)

 Rash maculo-papular

1 (0.1)

1 (0.1)

0 (0.0)

 Bronchospasm

1 (0.1)

0 (0.0)

0 (0.0)

 Conjunctivitis allergic

1 (0.1)

0 (0.0)

0 (0.0)

 Drug hypersensitivity

1 (0.1)

0 (0.0)

0 (0.0)

  1. Abbreviations: MedDRA Medical Dictionary for Regulatory Activities, N number of patients in the analysis population, n number of patients within each specific category, SMQ standardized MedDRA query
  2. aThese are likely events per medical review
  3. bCategorized by narrow standardized MedDRA®b (v.19.1) query search terms. MedDRA®, the certified Medical Dictionary for Regulatory Activities terminology, is the international medical terminology developed under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
  4. cIndicates a statistically significant difference (P < 0.05) compared with placebo